Pregabalin Versus Dexmedetomidine for Delirium Prevention After Cardiac Surgery

Delirium Clinical Trial

Official title:

Pregabalin Versus Dexmedetomidine for Delirium Prevention After Cardiac Surgery: A Randomized Double-Blind Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05640479
• Other study ID #: 35913/10/22
• Status: Recruiting
• Phase: Phase 4
• Start date: December 15, 2022
• Est. completion date: May 15, 2023

Study information

• Verified date: March 2023
• Source: Tanta University
• Contact: Islam Morsy, MD
• Phone: 00201093387374
• Email: eslam.morsy[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the effect of perioperative administration of pregabalin versus dexmedetomidine on the prevalence and lasting duration of delirium in elderly patients after cardiac surgery.

Description:

Pregabalin is a beta-isobutyl of GABA with chemical similarity to gabapentin . Pregabalin binds to the alpha-2-delta subgroup of calcium channels, thereby reducing excitatory neurotransmitter release and preventing hyperalgesia and central sensitization . Pregabalin is used as anticonvulsant but has also been used as analgesic for neuropathic pain and, lately, for postoperative pain, in an attempt to reduce opioid consumption and prevent progression to chronic pain.

Dexmedetomidine with its broad range of effects including easily controllable sedation, analgesia, and anxiolysis still enables the caring medical team to interact with the patient. It reduces the activity while still maintaining the reactivity of neurons in the locus coeruleus. Therefore, it is an appealing alternative to traditional sedatives such as propofol and benzodiazepines.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• = 65 years of age both genders American Society of Anesthesiologists (ASA) physical status classification II or III scheduled for cardiac surgery.

Exclusion Criteria:

• Patients who had history of psychiatric diseases; inability to communicate; previous history of POD; preoperative sick sinus syndrome.

• Allergy/sensitivity to pregabalin or dexmedetomidine.

• Severe bradycardia (heart rate <50 beat per minute).

• Second-degree or above atrioventricular block without pacemaker.

• Severe hepatic or renal insufficiency.

• Previous cardiac or thoracic surgery.

• Known diagnosis of depression or other major psychiatric diseases.

• Cognitive impairment or inability to cooperate with the study.

• Renal insufficiency, and history of substance abuse.

Related Conditions & MeSH terms

• Delirium
• Dexmedetomidine
• Pregabalin

Intervention

Drug:
• Pregabalin
patients will receive pregabalin capsules (75 mg) will be given 2 h prior to induction of anesthesia and every 12 hours
• Dexmedetomidine
patients will receive dexmedetomidine after induction of GA a bolus dose of 0.4 µg/kg dexmedetomidine (over a period of 10 to 20 min) followed by an infusion of 0.2 to 0.7 µg/kg/h

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	ElGharbiaa

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Delirium	Assessment of delirium will be performed preoperatively and postoperatively at 12-h intervals or as needed according to the patient's condition using the confusion assessment method (CAM)	24hour postoperatively
Secondary	Pain score	Postoperative pain (using VAS) at rest and movement will be measured at PACU, 1h, 2hr. 4hr, 6hr, 8hr, 12hr, 18hr, and 24hrs postoperative.; The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').	24 hours postoperatively
Secondary	Postoperative opioid consumption	Patients will receive single 3 mg dose of intravenous morphine and patient control analgesia (PCA) will be started with a programmable PCA pump using the following settings: basal morphine infusion 1 mg/h, bolus dose 1 mg, and lockout time 20 minutes.	24 hours postoperatively
Secondary	Sedation	Sedation level will be recorded using Sedation Agitation Scale	24 hours postoperatively
Secondary	Length of hospital stay	Patients will stay in hospital for one month	One month postoperatively